ThermaCare Heat Wraps Recall Lawsuit | 2026 Latest Updates

ThermaCare Heat Wraps were recalled in 2018 and again in 2019 by Pfizer Consumer Healthcare. Both actions were voluntary. The FDA classed them as Class 2 device recalls and lists all of them as Terminated. Six lots were pulled in 2018 over possible leaks. One lot was pulled in 2019 because a wrap could include cells hotter than specified. The notices describe a potential risk of burns/blisters and/or skin irritation. The 2018 and 2019 notices told consumers to stop using an affected wrap, record the lot number and throw it away without opening the foil pouch. They also said to call Pfizer’s information line for a replacement or reimbursement.

Latest ThermaCare Heat Wraps Recall Updates

June 11, 2024: FDA Terminates the April 2019 Recall

The FDA terminated the April 2019 recall of ThermaCare HeatWraps on June 11, 2024, according to the FDA record [1]. The record lists the action as Z-1496-2019. It is a Class 2 device recall with Recall Event ID 82781 and covers the Advanced Back Pain Therapy wraps. The FDA updates a record for a final time when the recall is terminated.

August 28, 2023: FDA Terminates the October 2018 Recalls

The FDA terminated the October 2018 recall records for ThermaCare HeatWraps on August 28, 2023. The first is Z-0554-2019 [2]. The second is Z-0555-2019 [3]. The third is Z-0556-2019 [4]. All three are Class 2 device recalls under Recall Event ID 81178. Together they cover the six ThermaCare lots that Pfizer recalled in 2018: S68516, T26686, T26691, T26693, 8054HA and 8054HB.

April 26, 2019: Pfizer Recalls One Lot of Back Pain Wraps

Pfizer Consumer Healthcare recalled one lot of ThermaCare Advanced Back Pain Therapy HeatWraps by press release on April 26, 2019. The FDA record covers 225,617 individual heat wraps. Notification packages went to direct consignees on April 29, 2019. They were told to stop distribution and return the product. Distributors were told to sub-recall, and retailers were asked to post the press release.

November 26, 2018: Pfizer Expands the Recall to Consumers

Pfizer Consumer Healthcare announced a voluntary consumer-level recall of six lots of ThermaCare HeatWrap on November 26, 2018, because the wraps could leak. The FDA-posted announcement carries the same date [5]. A notice went to direct accounts on November 27, 2018. The 2018 lots went to retailers, wholesalers and distributors in the United States, Puerto Rico and the U.S. Virgin Islands from September 2017 through August 2018.

October 2, 2018: Pfizer Starts the First 2018 Recall

Pfizer sent its first recall letter for six ThermaCare HeatWraps lots to direct accounts on October 2, 2018. The letter asked the accounts to sub-recall and return the lots. The FDA records list 119,232, 293,880 and 4,956 units across the three recall records. The company’s announcement says it notified its retailers of the recall that same day.

September 16, 2011: FDA Terminates the 2010 Recall

The FDA terminated the September 2010 recall of one lot of ThermaCare Menstrual wraps on September 16, 2011. The FDA’s record for the 2010 recall lists it as Z-0622-2011 [6]. The FDA classed it as Class 2. Its record names Wyeth Consumer Healthcare as the firm that sent the urgent recall letter for lot E06831 to direct accounts on September 24, 2010.

September 24, 2010: Pfizer Recalls One Menstrual Wrap Lot

Pfizer voluntarily recalled one lot of ThermaCare Menstrual 8 Hour Heat Wraps on September 24, 2010, according to Pfizer’s September 2010 press release [7]. The FDA record for this recall lists 192,000 cartons of three wraps. The wraps were sold nationwide in the United States and Puerto Rico. The company cited a potential for a leak that could cause skin injury such as irritation or burn.

Which ThermaCare Heat Wraps Are Affected?

The recalls covered these ThermaCare Heat Wraps, listed by recall year:

• 2018, Muscle Pain Therapy 8HR: lot S68516 (3+1 wraps per carton, UPC 305733013144) and lot T26686 (3 wraps per carton, UPC 305733013038). Both expire July 2020.
• 2018, Menstrual Pain Therapy 8HR: lot T26691 (3 wraps per carton, UPC 305733020029, expires July 2020) and lot T26693 (3+1 wraps per carton, UPC 305733020449, expires August 2020).
• 2018, Joint/Muscle Pain Therapy 8HR: bundled lots 8054HA and 8054HB, UPC 305733013113, expires July 2020. Each 11-count bundle holds one 3-count Muscle Therapy package and two 4-count Joint Therapy packages.
• 2019, Advanced Back Pain Therapy, up to 16HR (Lower Back and Hip Therapy, 2-count carton): master lot S97473, UPC 305733010037, used in 17 retail display case sub lots. The FDA record lists lots S23902, W37940 and S00639.
• 2010, Menstrual 8 Hour Heat Wraps, 3 count: lot E06831, expires August 2012, NDC 0573-3020-02, UPC 3-0573-3020-02-9.

Why Were ThermaCare Heat Wraps Recalled?

Pfizer recalled six lots of ThermaCare Heat Wraps in 2018 because those lots had a potential to leak ingredients in the heat cell wrap. The company announcement warns about a leaking or damaged heat cell wrap. It says use could cause skin injuries such as burns/blisters and/or skin irritation on the wrap applied area. The April 2019 recall of one lot followed a different problem. A HeatWrap could include cells with a higher cell temperature than specified. The FDA record says wraps with increased temperatures pose a potential risk of skin injuries such as burns/blisters and/or skin irritation.

Reported Incidents, Injuries, or Illnesses

None of the notices gives a number of injuries, illnesses or deaths. Pfizer received complaints of wraps coming apart and leaking granular material in 2018, according to the FDA record for the October 2018 recalls. The product label warns consumers not to use the product if heat cell contents leak and/or the wrap is damaged or torn. A complaint or a report is not proof that a wrap caused an injury. As of September 2, 2025, the Judicial Panel on Multidistrict Litigation‘s report of pending MDL dockets lists no MDL over ThermaCare Heat Wraps [8]. The report does not cover individual lawsuits or class actions.

What Should Consumers Do?

If you still have a wrap from an affected lot, take these steps, which come from the 2018 and April 2019 notices:

1. Record the lot number, found on the side of the carton and the back of the pouch, and stop using the wraps.
2. Throw the product away in its entirety without opening the foil pouch.
3. Call the Pfizer Consumer Healthcare Information Line at 1-800-323-3383 (Mon-Fri, 9am-5pm EST) for replacement or reimbursement.
4. Contact a healthcare provider about any problem that may be related to using the product.
5. Report adverse reactions or quality problems to the FDA through its MedWatch program, which takes reports from patients and consumers.

Frequently Asked Questions

Has There Been a ThermaCare Heat Wraps Recall?

Yes, there has been a ThermaCare Heat Wraps recall. Besides the 2018 and 2019 recalls, the FDA has a record of a September 2010 recall of one Menstrual 8 Hour Heat Wraps lot. Its Recall Event ID is 56855.

Is the ThermaCare Heat Wraps Recall Still Active?

The ThermaCare Heat Wraps recall is no longer active. The FDA’s footnote on each recall record points to Title 21 of the Code of Federal Regulations, section 7.55, for details about how a recall is terminated.

What Does a Class 2 Device Recall Mean?

A Class 2 device recall, the class the FDA gives the ThermaCare recalls, is one where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences. The FDA also applies it where the probability of serious adverse health consequences is remote.

Which Company Recalled the ThermaCare Heat Wraps?

Pfizer Consumer Healthcare, a division of Pfizer Inc., recalled the ThermaCare Heat Wraps in 2018. The FDA record for the April 2019 recall names PF Consumer Healthcare 1 LLC as the recalling firm.

Are ThermaCare Joint Therapy HeatWraps Part of the Recall?

ThermaCare Joint Therapy HeatWraps 8HR are not part of the 2018 recall on their own. The notice says they are not subject to the recall notification. It lists only the bundled packages that contain them.

Were ThermaCare Heat Wraps Sold Outside the United States?

ThermaCare Heat Wraps from the April 2019 recall were distributed outside the United States too. The FDA record lists worldwide distribution, including Ireland, the UK, Malta, the Netherlands, Germany and Switzerland. It is not a separate recall abroad.

References

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=172945
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=167682
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=167683
4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=167684
5. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-inc-issues-voluntary-nationwide-consumer-level-recall-six-lots-thermacarer-heatwraps-due
6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94656
7. https://www.prnewswire.com/news-releases/pfizer-consumer-healthcare-issues-voluntary-recall-of-one-lot-of-thermacare-heatwraps-menstrual-product-103729494.html
8. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-September-2-2025.pdf